Recall of Device Recall Portex Anaerobic Pulsator Arterial Blood Sampling Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical ASD, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 3
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tubes, vials, systems, serum separators, blood collection - Product Code JKA
  • Reason
    The outer box label is marked with the correct expiration date of 08/2016. the inner tyvek unit label is marked with 08-2017 which exceeds the actual expiration date by one year.
  • Action
    Smiths Medical notified American Medical Depot via telephone on 12 December 2014. Smiths Medical instructed them to put product at their location on hold. American Medical Depots customer will be instructed to return their unused product for replacement.


  • Model / Serial
    Lot Number: 2782094
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    US in the state of FL.
  • Product Description
    Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. || Reorder Number: G1392 || Product Usage: The Arterial Blood Sampling Kit is intended for sampling arterial blood for the measurement of blood gasses, Cooximetry, electrolytes, total magnesium, and metabolites, (Glucose and Lactate).
  • Manufacturer


  • Manufacturer Address
    Smiths Medical ASD, Inc., 10 Bowman Dr, Keene NH 03431-5043
  • Manufacturer Parent Company (2017)
  • Source